Synthes recalls sterile tube packaging for 2.4MM TI VA Locking Screw that may cause surgical delays if inner cap opens during use. Affected units include Lot 6L37876.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
Synthes is recalling sterile tube packaging for their 2.4MM TI VA Locking Screw that could cause surgical delays if the inner cap opens when the outer cap is removed. This risk occurs during surgical procedures when the screw needs to be used.
The inner cap might open when the outer cap is removed, or the entire inner tube might stay inside the outer tube. This prevents the screw from being properly removed and used, which could delay surgery.
Surgical teams using the recalled sterile tube packaging for 2.4MM TI VA Locking Screws during procedures. Patients undergoing surgery with this specific screw type are at risk of delayed procedures.
Check for the part number 04.210.124TS on the packaging. The affected lot number is 6L37876. This product is used in sterile tube packaging for surgical screws.
Look for the part number 04.210.124TS and lot number 6L37876 on the sterile tube packaging.
The inner cap might open when the outer cap is removed, or the entire inner tube might stay inside the outer tube, preventing the screw from being used and causing surgical delays.
Check for the part number 04.210.124TS and lot number 6L37876 on the sterile tube packaging.
The recall record does not specify a remedy, so contact Synthes directly for guidance.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0883-2020 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0883-2020 from Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
